39 applicants
Cogent Biosciences · 3 days ago
Associate Director/Director, Data Management
United States
Full-time
Remote
Director
7+ years exp
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Responsibilities
Accountable for data management activities for Cogent Biosciences clinical studies, coordinating tasks and deliverables across multiple programs
Oversee CRO data management activities that support ongoing clinical programs
Lead Data Management in cross-functional Study Team Meetings
Oversee project level data management strategy and manage DM project budgets
Provides input to improve data processes and organization in alignment with other development functions.
Identify and troubleshoot operational problems and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
Leads the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
Manage / assign responsibilities for Data Managers and act as primary Data Management contact and contributor for projects
Review clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis)
Ensures that Data Management Plans, SOPs and applicable established guidelines of national and international regulatory authorities are followed throughout the course of the studies.
Review / Develop DB clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations
Review / Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs
Oversee the User Acceptance Testing (UAT) of EDC databases by CRO and internal teams. Coordinate UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report
Ensure clinical data within EDC is of high quality to support lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding
Accountable for eDiary, PRO, and other electronic data collection on portable devices to make sure the design of data collection meets the scientific objective
Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB
Coordinate and communicate with DB vendors on consistent basis to address Clinical team’s requests, project plans, and/or eCRF development activities
Participates in the preparation and presentation of data, when applicable
Represent Data Management in Sponsor/Regulatory Agency assessments and/or audits
Qualification
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Required
Bachelor’s degree or higher in a scientific discipline
Minimum of 7 years of clinical data management experience in pharma/biotech
Proficient in clinical data collection, cleaning and analysis for Phase I- IV clinical trials in a pharmaceutical industry/clinical research company
Experience working in an outsourced data management model
Knowledge of and experience with EDC databases, CDASH/SDTM standards, medical terminology, medical coding dictionaries, and quality control processes
Familiarity with GCP, ICH and FDA requirements as applicable for clinical data management
Preferred
Prior experience filing an NDA
Ability to manage multiple initiatives and shifting priorities within a small company environment
Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
Benefits
Competitive pay
Performance-based bonus
Stock options
Insurance coverage (health, dental, life, and disability)
Competitive time-off
401(k) plan
Commuter/parking benefits
Company
Cogent Biosciences
Cogent Biosciences is a biotechnology company that develops therapies for solid cancer tumors.
51-200 employees
H1B Sponsorship
Cogent Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (3)
Funding
Current Stage
Public CompanyTotal Funding
$917.7MKey Investors
Commodore CapitalFairmount Funds ManagementSquare 1 Bank
2024-02-13Post Ipo Equity· $225M
2023-06-06Post Ipo Equity· $150M
2022-06-13Post Ipo Equity· $150M
Leadership Team
Geoffrey Hodge
SVP Operations
Cole Pinnow
Chief Commercial Officer
Recent News
Defense World
2024-06-04
2024-06-04
Company data provided by crunchbase
